Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)

September 20, 2016 updated by: Haruhiko Fukuda

A Randomized Phase III Trial of Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Carboplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)

To evaluate the clinical benefits of Paclitaxel plus Carboplatin compared with Paclitaxel plus Cisplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prognosis of the advanced, recurrent, or persistent cervical cancer, which is not amenable to curative treatment with surgery and/or radiation therapy, still remains poor. Recently, cisplatin plus paclitaxel for palliative chemotherapy were reported to improve the response rate and progression-free interval compared to cisplatin alone and has been shown as a new appropriate regimen. However, more effective and/or less toxic combinations are needed. Carboplatin as a single agent has less response rate but less overall toxicity than cisplatin. Particularly, because less nephrotoxicity does not require hydration and less neurotoxicity enables 3hrs administration of paclitaxel in the combination, out patient therapy becomes possible and patients' quality of life must improve. Therefore, we planned to evaluate the benefits of less toxicity of the chemotherapy containing paclitaxel and carboplatin, which could reduce the hospitalised days, in comparison with the standard chemotherapy containing paclitaxel and cisplatin. This clinical trial is targeted on the patients in Japan with incurable cervical cancer diagnosed by means of image.

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi, Japan, 460-0001
        • Nagoya Medical Center
    • Ehime
      • Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
        • National Hospital Organization Shikoku Cancer Center
    • Fukuoka
      • Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan, 811-1395
        • National Kyushu Cancer Center
      • Kurume, Asahi-machi, 67, Fukuoka, Japan, 830-0011
        • Kurume University School of Medicine
    • Gunma
      • Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center
    • Hiroshima
      • Kure,Aoyama-cho,3-1, Hiroshima, Japan, 737-0023
        • National Hospital Organization Kure Medical Center Chugoku Cancer Center
    • Hokkaido
      • North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
      • S-1,W-16,Chuo-ku,Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University
    • Hyogo
      • Akashi,Kitaouji-cho,13-70, Hyogo, Japan, 673-8558
        • Hyogo Medical Center for Adults
    • Ibaraki
      • Tsukuba,Tennodai,1-1-1, Ibaraki, Japan, 305-8575
        • Institute of Clinical Medicine,Tsukuba University Hospital
    • Kagoshima
      • Kagoshima,Kajiya-cho,20-17, Kagoshima, Japan, 892-8580
        • Kagoshima City Hospital
    • Miyagi
      • Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Nagano
      • Matsumoto,Asahi,3-1-1, Nagano, Japan, 390-8621
        • Sinshu University
    • Niigata
      • Nagaoka,Terashima-cho,297-1, Niigata, Japan, 940-2085
        • Nagaoka Red Cross Hospital
      • Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
    • Osaka
      • Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
        • Osaka Medical Center for Cancer and Cardiovascular Diseases
      • Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan, 534-0021
        • Osaka City General Hospital
      • Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan, 589-8511
        • Kinki University School of Medicine
    • Saga
      • Saga,Nabeshima,5-1-1, Saga, Japan, 849-8501
        • Faculty of Medicine, Saga University
    • Saitama
      • Kawagoe,Komoda,1981, Saitama, Japan, 350-8550
        • Saitama Medical Center, Saitama Medical School
      • Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Tokorozawa,Namiki,3-2, Saitama, Japan, 359-8513
        • National Defense Medical College
    • Tokyo
      • Bunkyo-ku,Hongo,3-1-3, Tokyo, Japan, 113-0033
        • Juntendo University School of Medicine
      • Bunkyo-ku,Hongo,7-3-1, Tokyo, Japan, 113-8655
        • The University of Tokyo Hospital
      • Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Koto-ku,Ariake,3-10-6, Tokyo, Japan, 135-8550
        • Cancer Institute Hospital
      • Minato-ku,Nishishinbashi,3-25-8, Tokyo, Japan, 105-8461
        • Jikei University Hospital
    • Tottori
      • Yonago,Nishimachi,36-1, Tottori, Japan, 683-8504
        • Tottori University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. histologically proven uterine cervical cancer
  2. squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix
  3. one of the followings, 1)primary stage Ⅳb cervical cancer, 2)the first relapse or persistent cervical cancer after curative first line treatments, 3)the second relapse or persistent cervical cancer after curative second line treatments including radiation, systemic chemotherapy, hormonal therapy, or vaccination therapy for the first relapse
  4. Patients may have been previously treated with less than 50 Gy of palliative radiation therapy
  5. Patients have received no prior treatment or a certain interval must have elapsed from the last administration of previous treatments including palliative radiation therapy
  6. one of the followings, 1)There is at least one metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN, 2)There is no metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN and some of the lesions have been irradiated, 3)All lesions are localized inside the pelvic cavity, and some of them have been irradiated
  7. no prior surgical therapy for metastatic lesions of the lung or inside the pelvic cavity
  8. no bilateral hydronephrosis
  9. no prior chemotherapy including more than two platinum-containing regimens
  10. no prior chemotherapy including taxane
  11. age: 20 to75 years
  12. PS: 0-2
  13. ANC ≧1,500 /mm3, Plt≧10.0×104/mm3, T-bil≦1.5 mg/dl, GOT（AST）≦100IU/l, sCre ≦1.2 mg/dl, Ccr≧50ml/min in using the Cockcroft-Gault equation, and normal ECG
  14. written informed consent

Exclusion Criteria:

  1. patients who have some neurologically functional disorder
  2. symptomatic CNS metastasis
  3. hypersensitive to alcohol
  4. active infection
  5. HBs antigen positive
  6. uncontrollable hypertension
  7. history of myocardiac infarction within six months
  8. unstable angina
  9. uncontrollable diabetes
  10. Patients with a concomitant or prior invasive malignancy (except intramucosal malignancy which are curable with local therapy) who have had any evidence of the disease within the last 5 years
  11. women during pregnancy or breast-feeding
  12. patients with psychiatric illness
  13. patients who have been treated with the systemic steroids medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Drug: chemotherapy: Paclitaxel/Cisplatin
Drug: chemotherapy: Paclitaxel/Cisplatin
Drug: chemotherapy: Paclitaxel/Cisplatin
Experimental: 2
Drug: chemotherapy: Paclitaxel/Carboplatin
Drug: chemotherapy: Paclitaxel/Carboplatin
Drug: chemotherapy: Paclitaxel/Carboplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: During the study conduct
During the study conduct

Secondary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: During the study conduct
During the study conduct
response rate
Time Frame: During the study conduct
During the study conduct
adverse events
Time Frame: During the study conduct
During the study conduct
severe adverse events
Time Frame: During the study conduct
During the study conduct
proportion of periods of non-hospitalization to those of the planned treatment
Time Frame: 18 weeks
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haruhiko Fukuda

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

  • Study Chair: Toshiharu Kamura, MD, PhD, Kurume University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (Estimate)

February 24, 2006

Study Record Updates

Last Update Posted (Estimate)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JCOG0505
  • C000000335 (Registry Identifier: UMIN-CTR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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